Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS

NCT06346847 | Completed

• 1 other identifier: TAC/231001/AKM/IBS
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 23

Brief Summary

The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of postbiotic on anxiety, low mood and stress of the participants, as well as its safety and tolerability. The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase).

Conditions

Diarrhea-Predominant Irritable Bowel Syndrome

Keywords

IBS

Outcome Measures

Primary Outcomes (1)

• To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome.

  A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)

  Baseline (Day 0), and Week 12 (Day 84)

Secondary Outcomes (13)

• To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8

  Baseline (Day 0) and Week 8 (Day 56)

• To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score

  Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)

• To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12.

  Baseline (Day 0) and Week 12 (Day 84)

• To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score

  Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105)

• To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12.

  Baseline (Day 0) and Week 12 (Day 84)

Study Arms (2)

Postbiotic

EXPERIMENTAL

1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks

Dietary Supplement: Postbiotic

Placebo

PLACEBO COMPARATOR

1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks

Dietary Supplement: Placebo

Interventions

Postbiotic DIETARY_SUPPLEMENT

1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks

Postbiotic

Placebo DIETARY_SUPPLEMENT

1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women from 18 to 55 years old.
• Individuals diagnosed for IBS within the last two years, and meets Rome-IV criteria for IBS: recurrent abdominal pain on average ≥1 day/week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria:
• Related to defecation
• Associated with a change in frequency of stool
• Associated with a change in form (appearance) of stool.
• Has IBS-D, i.e., more than ¼ (25%) of bowel movements with Bristol stool types 6 or 7 and less than ¼ (25%) of bowel movements with Bristol stool types 1 or 2); in other words, put practically and as per FDA: at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS.
• Has an IBS-SSS of at least 175 points at screening.
• Individuals either with abdominal pain or discomfort (≥ 6 to ≤ 10 on an 11-point scale).
• Has had no prior line of conventional intervention for IBS or dietary change in the last 4 weeks before screening (e.g., low FODMAP, soluble fibers, antispasmodics, laxatives, obstipants, serotonin agonist/antagonist) i.e., recently diagnosed individuals
• Individuals' agreement to comply with study procedures, in particular:
• to take IP as recommended,
• to avoid the use of other products which may influence the gastrointestinal (GI) complaints, mental symptoms or commensal flora during the study as defined in Section 6.8 Prior and Concomitant Therapy,
• to keep the habitual dietary habits, level of physical activity as well as the level of caffeine or nicotine (if any),
• to complete the individual's diary and study questionnaires.
• Women of childbearing potential:

You may not qualify if:

• Known allergy or hypersensitivity to the components of the investigational product.
• Smokers
• Lactose or fructose intolerance.
• Individuals with uncontrolled hypertension as assessed by systolic blood pressure ≥ to 160 mmHg and diastolic blood pressure ≥ to 100mmHg.
• History of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aorto-iliac disease) or recent unexplained GI bleeding within 3 months prior to screening.
• History of malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
• History and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., inflammatory bowel disease, coeliac disease, Clostridium difficile colitis, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc.)
• Major gastric, hepatic, biliary, pancreas or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred \> 3 months prior to study screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred \> 3 months prior to screening).
• Clinically significant findings in colonoscopy within the 3 years prior to study.
• Family history among first degree relatives of colorectal cancer or inflammatory bowel disease.
• Individuals diagnosed with psychiatric disease (e.g., bipolar disorder, Schizophrenia) with or without medication in the last three years.
• Individuals currently on medication for anxiety and/or depression
• Individual has a history and/or presence of other clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the participants, e.g.:
• thyroid gland disorder
• hypertension

Sponsors & Collaborators

• A-Mansia Biotech S.A.: lead
• Vedic Lifesciences Pvt. Ltd.: collaborator

Study Sites (23)

HCG Hospital

Ahmedabad, Gujarat, 380006, India

Location

Anand Multispeciality Hospital

Vadodara, Gujarat, 390016, India

Location

Stress Test Clinic

Mumbai, Maharashtra, 400059, India

Location

Criticare Asia Multispeciality Hospital & Research Centre

Mumbai, Maharashtra, 400069, India

Location

Surya Multispeciality Hospital

Nashik, Maharashtra, 422003, India

Location

Astha Clinic

Nashik, Maharashtra, 422011, India

Location

Apollo Hospital

Navi Mumbai, Maharashtra, 400614, India

Location

Swara Hospital

Pālghar, Maharashtra, 401303, India

Location

Gastrohub Hospital

Pune, Maharashtra, 411027, India

Location

Umarji Mother and Child Care Hospital

Pune, Maharashtra, 411045, India

Location

Lifeline Multispeciality Hospital

Pune, Maharashtra, 412101, India

Location

Asian Institute of Medical sciences

Thane, Maharashtra, 421203, India

Location

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan, 302039, India

Location

Samvedna Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

GCS Medical College, Hospital & Research Centre

Gujarat, 380025, India

Location

Nand Hospital

Gujarat, 390015, India

Location

Maharaja Agrasen Superspeciality Hospital

Jaipur, India

Location

Birch Multispeciality Hospital

Maharashtra, 411041, India

Location

Lifeline multispeciality hospital

Maharashtra, 412101, India

Location

Astha Clinic

Nashik, India

Location

Mata Roop Rani Maggo Hospital & IVF Center

New Delhi, 110059, India

Location

Ford Hospital

Uttar Pradesh, 221005, India

Location

Human care hospital

Uttar Pradesh, 226012, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: July 18, 2024
• Primary Completion: May 29, 2025
• Study Completion: July 13, 2025
• Last Updated: March 23, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (23)